Conservative Therapies in the Treatment of Temporomandibular Disorders: a Randomized Controlled Clinical Trial.

Status: Active_not_recruiting

Location: See location...

Intervention Type: Radiation, Device

Study Type: Interventional

Study Phase: Not Applicable

SUMMARY

The present study was designed to evaluate different conservative therapies in patients with temporomandibular disorders. A total of 160 patients will be selected after the diagnosis of TMD according to the Diagnostic Criteria for Temporomandibular Disorder (DC/TMD), axis I. Patients will be randomly divided into five groups: OD group (n=32): treated with an occlusal device; LLLT group (n=32): treated with infrared low-level laser; ODL group (n=32): treated with OD + LLLT; LAT group (n=32): treated with laser acupuncture and ODLAT group (n=32): treated with both OD and LAT. Patients undergoing therapy with a stabilizing plate (made using the simplified technique) will be instructed to use the device every night while sleeping for four weeks. In both the LLLT and LAT groups, the protocol involved five applications: one at baseline, followed by four subsequent weekly sessions. The intensity of pain will be classified using the Visual Analog Scale (VAS). Mandible function will be assessed by maximum unassisted mouth opening. The impact of therapies on oral health will also be evaluated using the Oral Health Impact Profile (OHIP-14) instrument in a simplified form.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Healthy Volunteers: f

View:

• Adults of legal age

• Both sexes

• Regardless of race or social class

• With the main complaint of pain in the temporomandibular joint or orofacial region

• With or without limitation of mouth opening, diagnosed through the DC/TMD axis1, with pain in the masticatory mm and muscular TMD

• Participants must have complete permanent dentition and normal occlusion.

Locations

Other Locations

Brazil

Universidade Federal de Alfenas

Alfenas

Time Frame

Start Date: 2023-03-01

Completion Date: 2025-09-30

Participants

Target number of participants: 160

Treatments

Experimental: Occlusal Splint

Participants allocated will receive therapy with a stabilizing plate made by the simplified technique. This plate is made of an acetate plate, plasticized in a plaster model, and individualized by acrylic resin. This technique allows the professional to make and install the plate in a short time, without the laboratory step, and is also more economical.~After the plate installation and adjustments, the participant will be instructed to use the device every night during sleep. Weekly adjustments will be performed for 4 weeks, and in these sessions information regarding the research parameters will be collected.

Experimental: Laser Therapy

All participants will be examined and pain trigger points will be identified, if any. The laser will be applied at predetermined points and at specific trigger points identified during the clinical examination. The application of the laser will be symmetrical, i.e. on both sides of the face, with the same number of points, regardless of whether it is a trigger point or not.~The equipment to be used and the parameters for the applications have the following characteristics: 808 nm wavelength, 100 mW of useful emitter power, 105 J/cm2 of energy density, spot area 0.028 cm2, Energy/point 3 J, 1 application per week for 4 weeks.

Experimental: Occlusal Splint + Laser Therapy

The therapies will be associated during the same period as the other groups, ensuring the same application and evaluation protocols.

Experimental: Acupuncture Laser Therapy

The laser will be applied to predetermined acupuncture points and specific trigger points identified during the clinical examination. The application will be performed symmetrically and bilaterally, regardless of the presence of trigger points. A standardized protocol will be followed for all participants, irrespective of tissue thickness or gender. The equipment to be used will emit an infrared light beam with a wavelength of 808 nm, output power of 100 mW, energy density of 105 J/cm², and a spot size of 0.028 cm², delivering 3 J per point, which corresponds to a 30-second application per point. The protocol will consist of five applications: one at baseline, followed by four weekly sessions.

Experimental: Occlusal Splint + Acupuncture Laser Therapy

In the combined therapy group, the therapies will be administered simultaneously with those of the other groups, ensuring standardized protocols for application and evaluation throughout the study period.

Similar Clinical Trials

View All

Conservative Therapies in the Treatment of Temporomandibular Disorders: a Randomized Controlled Clinical Trial.

Similar Clinical Trials

Effect of Exercises on Convergence Insufficiency in Individuals With Temporomandibular Disorders: Clinical, Randomized, Blinded Trial

Effect of Exercises on Convergence Insufficiency in Individuals With Temporomandibular Disorders: Clinical, Randomized, Blinded Trial

Tele-Rehabilitation in Patients With Temporomandibular Dysfunction: Randomized, Controlled and Blind

Tele-Rehabilitation in Patients With Temporomandibular Dysfunction: Randomized, Controlled and Blind

Evaluation of the Efficacy of Cervical Core Exercises in Persons With Temporomandibular Joint Dysfunction

Evaluation of the Efficacy of Cervical Core Exercises in Persons With Temporomandibular Joint Dysfunction